Scientist, Analytical Development

Scientist, Analytical Development Job Description Template

Our company is looking for a Scientist, Analytical Development to join our team.

Responsibilities:

  • Selected candidate will report to the Director of Analytical Development;
  • Develop analytical testing strategies based on provided customer technical package and/or process development synthetic routes;
  • Collaborate with customers and other functional areas to advance projects through development;
  • Author reports and review data;
  • Execute method validation protocols for the CGMP release of drug substance batches;
  • Develop new analytical methods;
  • Assess customer methods for validation readiness;
  • Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams;
  • Serves as a technical mentor for junior staff and leverages technical expertise as a functional resource/trainer;
  • Contributes significantly and independently to project work which may include multiple projects within functional area;
  • Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team;
  • Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies;
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders;
  • Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary;
  • Responsible for integrating scientific/technical efforts around cross-functional issues.

Requirements:

  • PhD in biochemistry, cell and molecular biology or related pharmaceutical science; 0-2 years relevant industry experience;
  • Understanding of viral transduction process and viral analytics is strongly preferred;
  • Extensive knowledge of hematopoietic stem cell biology and/or red blood cell physiology is strongly preferred;
  • Understanding and experience of analytical assay validation is a plus.